The Recall Desk
SevereFDA (Drugs)·D-1805-2019·Announced 2019-08-21

Infusion Options Recalls Pertuzumab IV Bags Due to Sterility Concerns

Infusion Options, Inc. is recalling Pertuzumab IV bags in New York due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports, or high-risk contamination.

Plain-English summary

Infusion Options, Inc. is recalling Pertuzumab 840 mg/250 mL 0.9% NaCl IV bags. The recall was initiated because of a lack of assurance of sterility.

The affected product is a prescription-only medication distributed in New York. All lots within the expiration date are included in this recall.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — IV Infusion
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 76 recalled by Infusion Options, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 76 products in this recall →

Related recalls

Same manufacturer · Infusion Options, Inc.

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Same hazard · sterility

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